Quality Investigator

The Quality Investigator will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for. The Quality Investigator is responsible for identifying and resolving quality issues by conducting detailed investigations and analyzing root causes. The Quality Investigator work with cross-functional teams to implement corrective and preventive actions to ensure compliance with quality standards. This role supports continuous improvement to maintain product and process integrity. YOUR ROLE Investigate and complete site related exceptions minor and major investigations or critical investigations with coaching based on demands of the department. Identify root cause and recommend appropriate CAPAs to address root cause. Perform Phase II OOS investigations. Supports external audits from regulatory agencies and customers (i.e., Document Runner, Documentation Pre-Review, Scribe, etc.). Assist in the department in trending of metrics (i.e., Cost of Poor Quality, Key Performance Indicators, Quality Management Reviews, & Data Trend Analysis). Support data compilation for department requirements related to site Annual Product Reviews (APRs). Participate as a team member for site Kaizens or brainstorming initiatives to drive continuous improvement. Ability to perform SOP revisions as needed. Prepare GEMBA plans and perform walks to drive compliance and improve safety at the site. Ability to track the performance of assignments through to completion and meet with management on a weekly basis to report progress. The position will require independent decisions and personal judgment based on Company policies, SOPs, and GMPs. Proficiency in SAP. Performs other duties as assigned by management YOUR BACKGROUND Required Qualifications Bachelor’s degree in chemistry, Microbiology, Biology or Engineering is preferred Other science-related degrees may be considered Actual job experience may be used in lieu of degree Minimum 3-5 years’ experience in a pharmaceutical, biological or other FDA-regulated industry setting is preferred. Preferred Qualifications Familiarity and skilled competency with computers. Familiarity and skilled competency with MS Office software (Word, Excel and Outlook) environment. #J-18808-Ljbffr